Smart Fit Knee 3.0T

• K Number: K233600
• Device Name: Smart Fit Knee 3.0T
• Manufacturer: Philips Healthcare (Suzhou) Co., Ltd.
• Date Cleared: 2024-02-05 ( 88 days)
• Product Code: MOS
• Regulation Number: 892.1000

Intended Use

The Smart Fit Knee 3.0T coil is designed to be used in conjunction with a Philips 3.0T MR system to produce diagnostic images of the Knee that can be interpreted by a trained physician.

Device Description

The Smart Fit Knee 3.0T coil is designed to be used in conjunction with a Philips 3.0T MR system to produce diagnostic images of the Knee that can be interpreted by a trained physician. The Smart Fit Knee 3.0T is a 16-element coil designed for high-resolution imaging of the left or right knee. It is a phased-array, Rx volume coil providing an integrated solution with a base plate, an anterior and a posterior part. Positioning pads are also supplied to support comfortable positioning. The coil can be slightly rotated relative to its base plate to ease coil setup and enhance patient comfort. The coil is used independently and cannot be combined with any other coils. This coil is available for 3.0T MR systems and is compatible with Philips 3.0T MR Scanners.

Predicate Devices

K033567

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the hardware (coil design, elements, phased-array) and its function in receiving and transmitting signals for standard MRI image processing. There is no mention of AI/ML in the device description, intended use, or performance studies.

Therapeutic

No.
The device is used to produce diagnostic images, not for therapy.

Diagnostic

No

The device is an MR coil designed to produce diagnostic images. It is hardware used with a diagnostic imaging system, but it does not interpret the images or provide a diagnosis itself. The text states the images "can be interpreted by a trained physician," indicating the diagnostic function resides with the physician, not the coil.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "16-element coil" with physical components like a base plate, anterior and posterior parts, and positioning pads. This indicates it is a hardware device, not software-only.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
• Device Function: The Smart Fit Knee 3.0T coil is an accessory for an MRI system. Its function is to receive the magnetic resonance signal from the patient's knee in vivo (within the living body) and transmit it to the MRI system for image processing. It does not analyze or test samples taken from the body.
• Intended Use: The intended use is to produce diagnostic images of the knee, which are then interpreted by a physician. This is a form of in vivo imaging, not in vitro testing.

Therefore, the Smart Fit Knee 3.0T coil falls under the category of medical imaging devices, not In Vitro Diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Smart Fit Knee 3.0T coil is designed to be used in conjunction with a Philips 3.0T MR system to produce diagnostic images of the Knee that can be interpreted by a trained physician.

Product codes (comma separated list FDA assigned to the subject device)

MOS

Device Description

The Smart Fit Knee 3.0T coil is designed to be used in conjunction with a Philips 3.0T MR system to produce diagnostic images of the Knee that can be interpreted by a trained physician. The Smart Fit Knee 3.0T is a 16-element coil designed for high-resolution imaging of the left or right knee. It is a phased-array, Rx volume coil providing an integrated solution with a base plate, an anterior and a posterior part. Positioning pads are also supplied to support comfortable positioning. The coil can be slightly rotated relative to its base plate to ease coil setup and enhance patient comfort. The coil is used independently and cannot be combined with any other coils. This coil is available for 3.0T MR systems and is compatible with Philips 3.0T MR Scanners.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

MR (Magnetic Resonance)

Anatomical Site

Knee

Indicated Patient Age Range

Philips Rx coils are intended for any patient who requires an MR examination, and for whom the use of the coil provides an additional diagnostic benefit (in terms of Field of View or Signal-to-noise ratio) according to the clinical user. Exceptions to admissible patients relate to their physical characteristics (circumference, mass) in relation to coil dimensions.

Intended User / Care Setting

Trained physician

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

The performance test results demonstrate that the proposed Smart Fit Knee 3.0T meets the acceptance criteria and is adequate for its intended use. Additionally, the risk management activities show that all risks are sufficiently mitigated, that no new risks are introduced, and that the overall residual risks are acceptable.

All clinical images on the proposed coils Smart Fit Knee 3.0T were evaluated by qualified radiologists. No issues with the clinical image quality were seen and images were considered have sufficient quality for diagnostic use.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K033567

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 892.1000 Magnetic resonance diagnostic device.

(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Summary

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February 5, 2024

Philips Healthcare (Suzhou) Co., Ltd. Sherry Li Regulatory Affairs Specialist No. 258, Zhongyuan Road, Suzhou Industrial Park Suzhou, Jiangsu 215024 China

Re: K233600

Trade/Device Name: Smart Fit Knee 3.0T Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: MOS Dated: November 3, 2023 Received: November 9, 2023

Dear Sherry Li:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Daniel M. Krainak, Ph.D. Assistant Director DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

Submission Number (if known)

Device Name

Smart Fit Knee 3.0T

Indications for Use (Describe)

The Smart Fit Knee 3.0T coil is designed to be used in conjunction with a Philips 3.0T MR system to produce diagnostic images of the Knee that can be interpreted by a trained physician.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(k) Summary

| Date

Prepared:	November 09, 2023
Manufacturer:	Philips Healthcare (Suzhou) Co., Ltd.
	No. 258, Zhongyuan Road, Suzhou Industrial Park, Suzhou Jiangsu, CHINA, 215024
	Establishment Registration Number: 3009529630
Primary
Contact
Person:	Sherry Li
	Regulatory Affairs Specialist
	Phone: [phone]
	E-mail: [e-mail]
Secondary
Contact
Person	Leo Louis
	Regulatory Affairs Director
	Phone: [phone]
	E-mail: [e-mail]
Device Name:	Smart Fit Knee 3.0T
Classification:	Classification name:	Magnetic Resonance Diagnostic Device
	Classification Regulation:	21CFR 892.1000
	Classification Panel:	Magnetic Resonance Diagnostic Device
	Device Class:	Class II
	Primary Product Code:	MOS
Predicate
Device for
Smart Fit 3.0T	Trade name:	HRK-127-8 KNEE ARRAY COIL
	Manufacturer:	MRI Devices Corporation, 1515 Paramount Drive,
Waukesha, Wisconsin 53186, U.S.A.
	510(k) Clearance:	K033567
	Classification Regulation:	21CFR 892.1000
	Classification name:	Magnetic Resonance Diagnostic Device
	Classification Panel:	Radiology
	Device class	Class II
	Product Code:	MOS
Device Description:	The Smart Fit Knee 3.0T coil is designed to be used in conjunction with a Philips 3.0T MR system to
produce diagnostic images of the Knee that can be interpreted by a trained physician.
The Smart Fit Knee 3.0T is a 16-element coil designed for high-resolution imaging of the left or right
knee. It is a phased-array, Rx volume coil providing an integrated solution with a base plate, an
anterior and a posterior part. Positioning pads are also supplied to support comfortable positioning.
The coil can be slightly rotated relative to its base plate to ease coil setup and enhance patient
comfort.
The coil is used independently and cannot be combined with any other coils. This coil is available for
3.0T MR systems and is compatible with Philips 3.0T MR Scanners.
Indications for Use:	The Smart Fit Knee 3.0T coil is designed to be used in conjunction with a Philips 3.0T MR system
to produce diagnostic images of the Knee that can be interpreted by a trained physician.
Substantial Equivalence:	The 510(k) summary contains a summary of the technological characteristics of the proposed Smart
Fit Knee 3.0T compared to the predicate devices HRK-127-8 KNEE ARRAY COIL (K033567).
Table 1
Comparison of the primary currently marketed and predicate device, HRK-127-8 KNEE ARRAY
COIL versus the proposed Smart Fit Knee 3.0T
	Proposed Device, Smart Fit Knee 3.0T	Primary Currently Marketed and Predicate Device, HRK-127-8 KNEE ARRAY COIL	Conclusion
Design features
	Appearance	Image: Smart Fit Knee 3.0T	Image: HRK-127-8 KNEE ARRAY COIL	Similar.
The differences in appearance between products are not
expected to trigger a clinically significant difference in
clinical performance or safety of the device.
	Coil Dimensions
Length X
Width X
Height	LXWXH = 538 X 280 X 293mm	LXWXH = 300 X 250 X 285mm	Similar.
Smart Fit Knee 3.0T is
designed to be assembled on
a baseplate, so it's larger. The
differences in appearance between products are not
expected to trigger a clinically significant difference in
clinical performance or safety of the device.
	Type of coil	Phased-array Receive only coil	Phased-array Receive only coil	Same.
	Number of Channels /	16 Channels, 16 Preamplifiers	8 Channels, 8 Preamplifiers for	Similar.
Preamplifiers		Trio 3.0T System.
6 Channels, 8 Preamplifiers for
Philips Intera 3.0T system.	The differences in number of
channels and preamplifiers
between products are not
expected to trigger a clinically
significant difference in
clinical performance or safety
of the device.
System
Connector /
Compatibility
and coil
connector	Analogue connector mating face
with dStream Interface 3.0T which
has a DCI connector mating face
with system.	Has a standard coil connector
to connect the coil directly to
an MRI system.	Similar.
The differences between
products are not expected to
trigger a clinically significant
difference in clinical
performance or safety of the
device.
Application
site / body
part	Knee.	Knee.	Same.
Patient
population	Philips Rx coils are intended for any
patient who requires an MR
examination, and for whom the use
of the coil provides an additional
diagnostic benefit (in terms of Field
of View or Signal-to-noise ratio)
according to the clinical user.
Exceptions to admissible patients
relate to their physical
characteristics (circumference,
mass) in relation to coil dimensions.	Intended for use on the order
of a physician, in conjunction
with a magnetic resonance
(MR) scanner, as an accessory
to produce images of the
anatomy of interest, as an aid
to diagnosis/ treatment.	Same.
Although the wording is
different, the meaning is the
same. No difference in
characteristics between
products.
Intended Use
Intended use	Philips Magnetic Resonance (MR)
Receive-only (Rx) coils are intended
to be used in conjunction with a
Philips MR-system to enable
trained physicians to obtain cross-
sectional images of the internal
structure of the head, body, or
extremities, in any orientation.
These images, when interpreted by
a trained physician, provide
information that may assist
diagnosis and therapy planning.	To be used in conjunction with
a Magnetic Resonance
Scanner to produce diagnostic
images of the knee that can
be interpreted by a trained
physician.	Same.
Although the wording is
slightly different the meaning
is the same. No difference in
characteristics between
products.
	Fundamental Scientific Technology
Type of coil	Phased-array Receive only coil	Phased-array Receive only coil	Same.
Magnetic
Field
Orientation	Head-Feet oriented	Head-Feet oriented	Same.
(B0)
Frequency
range	127.728MHz+/-0.75MHz	127.728MHz+/-0.75MHz	Same.
Decoupling
method	Overlap, pre-amp decouple,
Active/Passive PIN diode
decoupling	Overlap, pre-amp decouple,
Active/Passive PIN diode
decoupling	Same.
Energy source	Derived from MR scanner, no
internal energy source	Derived from MR scanner, no
internal energy source	Same.
Housing
Material	PC and PU.	Plastic.	Similar.
PC is also a type of plastic. The
safety of PC and PU has been
proved in the biocompatibility
report. The differences
between products are not
expected to trigger a clinically
significant difference in
clinical performance or safety
of the device.
Base Pad	PCB	PCB	Same.
Principle of
operation	The coil receives magnetic
resonance signals generated in
hydrogen nuclei (protons) in the
human body while blocking the
radio frequency magnetic field
applied by the MRI system at
specified timings. The received
signal is amplified and transmitted
to the MRI system, where it is
processed into tomographic images
by the computer.	The coil receives magnetic
resonance signals generated
in hydrogen nuclei (protons)
in the human body while
blocking the radio frequency
magnetic field applied by the
MRI system at specified
timings. The received signal is
amplified and transmitted to
the MRI system, where it is
processed into tomographic
images by the computer.	Same.
Biological characteristics	Philips MR RF Rx coils are non-invasive surface devices that are only in contact with covered and/or intact patient skin
with limited exposure (